Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

NCT01812044 | Completed Results

• 1 other identifier: Pro00033000
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

• Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale

  Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for "Average pain score over the first 30 post-operative minutes using the CHEOPS scale." for each group.

  0-30 minutes post-operative

Secondary Outcomes (7)

• Peak Pain Score

  0-150 minutes post-operative

• Total Narcotic Use During Post-operative Recovery

  Total time in post-operative recovery - up to 6 hours

• Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)

  1 week (+/- 3 days) post operatively

• Average Time to Discharge

  0-150 minutes post-operative

• Number of Participants With Post Operative Nausea and Vomiting

  0-150 minutes post-operative

Study Arms (3)

subtenons anesthetic and topical control

OTHER

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%; Drug: topical control - 0.5 cc of Hypromellose 0.3% gel

topical anesthetic and subtenons control

OTHER

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel; Drug: subtenons control - 0.5 cc of Normal Saline

topical control and subtenons control

OTHER

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

Drug: topical control - 0.5 cc of Hypromellose 0.3% gel; Drug: subtenons control - 0.5 cc of Normal Saline

Interventions

subtenons anesthetic - preservative-free bupivacaine 0.75% DRUG

subtenons anesthetic and topical control

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel DRUG

topical anesthetic and subtenons control

topical control - 0.5 cc of Hypromellose 0.3% gel DRUG

subtenons anesthetic and topical control; topical control and subtenons control

subtenons control - 0.5 cc of Normal Saline DRUG

topical anesthetic and subtenons control; topical control and subtenons control

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1 year to \< 8 years
• Undergoing strabismus surgery under general anesthesia
• No previous surgery on muscle to be operated
• No known allergy to lidocaine or bupivacaine
• Investigator willing to inject subtenons NS or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or Hypromellose 0.3% gel (GenTeal Severe Dry Eye Relief) to all surgical wounds at the end of strabismus surgery.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Strabismus

Interventions

Gels

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Laura Enyedi, M.D.
• Organization: Duke University Medical Center

laura.enyedi@dm.duke.edu

919-684-2038

Study Officials

• Laura Enyedi, MD

  Duke Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: April 26, 2016
• Results First Posted: April 26, 2016

Record last verified: 2016-03

Locations

US (1)